Qa Staff(senior Quality Specialist)

PPD (Thermo Fisher)

Licensed pharmacist in japan
Gmp and qms knowledge
Batch record review experience
This role serves as a Quality leadership position within Thermo Fisher Scientific to ensure excellence in Quality Assurance operations

Job Summary

  • This role serves as a Quality leadership position within Thermo Fisher Scientific to ensure excellence in Quality Assurance operations.
  • The successful candidate will lead the team in maintaining product quality and regulatory compliance while supporting the manager as needed.
  • Key responsibilities include leading customer audits, managing deviations, and liaising with Japanese regulatory authorities regarding business licenses.

Matching Summary

This role serves as a Quality leadership position within Thermo Fisher Scientific to ensure excellence in Quality Assurance operations.

Skills & Requirements

Must-have

  • Licensed Pharmacist in Japan
  • GMP and QMS knowledge
  • Batch record review experience
  • Deviation management skills
  • Customer audit support

Nice-to-have

  • 2+ years QA or manufacturing experience
  • FDA, EMA, ICH regulatory knowledge
  • Risk-based approach implementation
  • English meeting communication skills

Key Requirements

  • Licensed Pharmacist qualification required
  • Knowledge of Pharmaceuticals and Medical Devices Act
  • Business-level English reading and writing capability

Work Rights

Must have Licensed Pharmacist in Japan

Tailored Resume

Cover Letter